Idiopathic ventricular fibrillation unexplained sudden cardiac arrest
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must be >= 18 years old and meet one of the following criteria:- All unexplained polymorphic VT or VF survivors in whom known structural myocardial, respiratory, metabolic and toxicological causes have been excluded through clinical evaluation*, with/without a genetic mutation. NB. If results of a diagnostic tests show minor abnormalities but insufficient for a specific diagnosis, this is no exclusion criterion. - Selected family members of these patients* - Control subjects with structurally normal hearts with a clinical indication for a cardiac CT scan, as already approved in METC protocol NL32128.068.11 (ABR number 32128). *All 1st and 2nd degree family members being in contact with the cardiologist/treating physician as part of cascade screening will be contacted. Family members must be in adequate health to be able to travel to the hospital for research purposes. 3rd degree family members in contact with the cardiologist/treating physician can also be contacted if at least one of the following criteria is met: • The family member has the same genetic mutation as index patient, or; • The family member has demonstrated ventricular arrhythmias, or; • The clinician has a very strong suspicion of ventricular arrhythmias in the family member. leden) t
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:- A known strong reaction against electrode attachment or contrast agent. - Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study. - Pregnancy, nursing or planning to be pregnant. - Subject has an estimated glomerular filtration rate (eGFR) of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study parameters are reconstructions of epicardial potentials, and electrocardiographic quantitative and qualitative measures based on body-surface potential maps. From these, relevant endpoints can be determined, i.e. *normal/abnormal activation or recovery patterns* and *increased dispersion of repolarization*. | — |
Secondary
| Measure | Time frame |
|---|---|
| At inclusion: - Baseline: age, gender, ethnicity, index event, circumstances index event, medical history, family history - Clinical data: ECG, blood chemistry (Na+, K+, Ca2+, Mg2+, cardiac enzymes, thyroid function), toxicology (drugs, intoxications), echocardiography, exercise stress test, Holter, CAG/CT-angiography, MRI, provocation tests (sodium channel blocker, ergonovine, epinephrine), EP study. - Genetics: DNA stored, method of genetic analysis, family screening. - Other/ if performed: SA-ECG, nuclear imaging, cardiac biopsy. - ECGI: BSP mapping and a cardiac + low dose thoracic CT-scan - Parameters acquired by strain echocardiography Data used for the registry at follow up, part of routine standard care (in the first year every six months, yearly control after one year): - Clinical data: ECG, exercise test, echocardiography, Holter - If patient received an ICD: appropriate shocks, inappropriate shocks, other ICD complications during follow up - Outcome: specific underlying diagnosis revealed during follow-up, death, cause of death | — |
Countries
Netherlands
Outcome results
None listed